Concussion
Conditions
Brief summary
The proposed study is a pilot randomized trial of a stepped collaborative care intervention designed to decrease post-concussive symptoms and improve post-injury functioning among sports-injured youth aged 11-17. Participants with persistent post-concussive symptoms (symptoms persisting at least two months post-injury) will be recruited from Seattle Children's Hospital departments of sports medicine and rehabilitation medicine. Consent and assent will be obtained in-person. Participants will be randomized to receive either the stepped collaborative care intervention, or treatment-as-usual. Participants will be assessed on a range of symptoms and areas of functioning at four time points: 0 months, 1 month, 3 months, and 6 months after enrollment. The primary hypothesis is that the intervention group athletes, when compared to usual care control group athletes, will demonstrate clinically and statistically significant reductions in postconcussive, anxiety, and depressive symptoms over the course of the 6-month study. Secondary analyses will assess the impact of the intervention on functional impairment including missed school days and other academic outcomes. Exploratory analyses will examine MRI findings that are characteristic of postconcussive neuropathology, if available in medical record, as predictors of treatment responses.
Interventions
BEHAVIORALStepped Care
Intervention will include : 1) care management; 2) cognitive-behavioral therapy (CBT); 3) psychiatric medication consultation in addition too receiving standard care through their medical team. Care management will include initial consultation to determine participants' and families' concerns and areas of difficulty, followed by brief interventions to connect them with care providers as needed . If participants do not show adequate symptom reduction, they will be engaged in structured CBT. CBT will be delivered in 4 to 12 structured sessions, each ranging from 30-60 minutes in length. Psychiatric medication consultation will be offered on an as-needed basis for participants not adequately responding to prior stepped care interventions. MD providers with expertise in psychopharmacological treatment of youth will provide consultation for participants' primary care provider regarding the prescription of psychiatric medications.
Sponsors
University of Washington
Seattle Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
11 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Between ages 11 and 18 * Have sustained a head impact during sports participation * Have incurred an onset or increase of at least three post-concussive symptoms following head impact * Have increased post-concussive symptoms following head impact have continued for at least 4 weeks * Live with their parents or legal guardians * Live within commuting distance of Seattle Children's Hospital * Willing to participate in assessment and treatment * Have at least one parent/caregiver willing to participate in assessment and treatment
Exclusion criteria
* Meet Diagnostic and Statistical Manual of Mental Disorders (DSM - V) criteria for a psychotic disorder or bipolar disorder * Active suicidality * Substance dependence
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Anxiety Symptoms | At enrollment, 1 month, 3 months, and 6 months | PROMIS A-8 |
| Change in Quality of Life | At enrollment, 1 month, 3 months, and 6 months | PedsQL |
| Change in Concussion Symptoms | At enrollment, 1 month, 3 months, and 6 months | Health Behavior Inventory Assessment |
| Change in Depressive Symptoms | At enrollment, 1 month, 3 months, and 6 months | PHQ-9 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in ImPACT Assessment | At enrollment and 6 months | ImPACT test scores |
| NIH Toolbox - Dimensional Card Sort Test | At enrollment and 6 months | Dimensional Card Sort Test scores |
| Change in School Functioning | At enrollment, 1 month, 3 months, and 6 months | Attendance and Grades |
| Change in King-Devick Test | at enrollment and 6 months | King-Devick Test scores |
| Change in NIH Toolbox - Picture Memory Sequence Test | At enrollment and 6 months | Picture Memory Sequence test scores |
| Change in Family Functioning | At enrollment, 1 month, 3 months, and 6 months | FAD-GF |
| Change in Parent Anxiety Symptoms | At enrollment, 1 month, 3 months, and 6 months | PROMIS A-8 |
| Change in Parent Depressive Symptoms | At enrollment, 1 month, 3 months, and 6 months | PHQ-9 |
Countries
United States
Outcome results
None listed